Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05081609 | A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 320 | — | — | Jan 11, 2022 | Aug 1, 2029 | Feb 24, 2026 | 68 | United States, Australia +8 |
Treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths.
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
To determine a recommended phase 2 dose of TransCon IL-2 β/γ and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
| Arm | Type | Description |
|---|---|---|
| Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ | EXPERIMENTAL | TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D |
| Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab | EXPERIMENTAL | TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo | EXPERIMENTAL | TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist | EXPERIMENTAL | TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery | EXPERIMENTAL | (Optional Arm): TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery | EXPERIMENTAL | TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery | EXPERIMENTAL | TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery | EXPERIMENTAL | TransCon IL-2 β/γ using the RP2D with Pembrolizumab and SOC Chemotherapy followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion | EXPERIMENTAL | TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D with Pembrolizumab |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ monotherapy | EXPERIMENTAL | TransCon IL-2 β/γ monotherapy |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab | EXPERIMENTAL | TransCon IL-2 β/γ + trastuzumab |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1) | EXPERIMENTAL | TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1) |
| Part 4 Combination Dose Optimization | EXPERIMENTAL | TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab |
| Name | Type | Description |
|---|---|---|
| TransCon IL-2 β/γ | DRUG | TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as an intravenous (IV) infusion |
| Chemotherapy drug | DRUG | SOC chemotherapy will be administered as an intravenous (IV) infusion |
| TransCon TLR7/8 Agonist | DRUG | TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection |
| Surgery | PROCEDURE | Surgery will take place 4-6 weeks after last dose of study treatment. |
| Trastuzumab | DRUG | Trastuzumab will be administered as an intravenous (IV) infusion |
| Trastuzumab emtansine (T-DM1) | DRUG | Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion |
Key Inclusion Criteria: * At least 18 years of age, or country defined local legal age * Demonstrated adequate organ function at screening * Life expectancy \>12 weeks as determined by the Investigator * Female and male participants of childbearing potential who are sexually active must agree to us...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |